<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20100130003227N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-24</date_registration>
      <primary_sponsor>Khomain University of Medical Sciences</primary_sponsor>
      <public_title>The effect of herbal ointment including Plantago major L and Rosa damascene on bed sore.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of herbal ointment including Plantago major L and Rosa damascene on the bed sore of hospitalized patient</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34230</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals will be assigned into the intervention or control groups using a random numbers table, Blinding description: Participants will be blinded for allocation into intervention or control groups due to randomization and will not be informed about the intervention type (Dressing with herbal ointment combing honey, tufted bell pepper and spinach or dressing with Comfeel, which is commonly used to repair bed litter.) before study initiation. Outcome assessors will not be informed about the patients categorization.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Bed sore.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention consists of placing a layer of herbal ointment consisting of honey, Plantago major L and Rosa damascene on the wound (bed sore) to the required amount (based on the size, amount and type of secretion of the wound), after washing and scrubbing (rinsing with 0.9% normal serum serum) Which was covered with a layer of sterilized gas. Wound dressing was carried out in both groups under equal conditions (number of dressing changes in 24 hours, duration and manner of washing). In this study, to prepare this ointment, 1.5 grams of the Plantago major L in 25 ml of water and 1 g of the Rosa damascene in 25 ml of water are brewed and mixed with 50 g of honey and For every dressing, was used. After preparing the ointment, pouring some ointment in a can for each patient and labeling the name of each patient on the can were done. Dressing was done by two trained observer (one man and one female) about the method of dressing the bed sore, one to three times a day (depending on the condition of the wound) until complete wound healing. Observers took an observation measure (PUSH: pressure ulcer score for healing) before the intervention and then every week at a specified hour to determine the instrument scores. The Braden tool was used to control the confounding factors such as patient mobility, sensory perception, skin moisture, degree of physical activity, and nutritional status of patients. Intervention 2: Control group: The intervention involves placing a layer of Comfeel on the wound (bed sore) to the required amount (based on the size, amount and type of secretion of the wound), after washing and scrubbing (rinsing with 0.9% normal serum serum) Which was covered with a layer of sterilized gas. Wound dressing was carried out in both groups under equal conditions (number of dressing changes in 24 hours, duration and manner of washing). Dressing was done by two trained observer (one man and one female) about the method of dressing the bed sore, one to three times a day (depending on the condition of the wound) until complete wound healing. Observers took an observation measure (PUSH: pressure ulcer score for healing) before the intervention and then every week at a specified hour to determine the instrument scores. The Braden tool was used to control the confounding factors such as patient mobility, sensory perception, skin moisture, degree of physical activity, and nutritional status of patients.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohhammad Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qods Blvd.</address>
        <city>Khomein</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>38817-43364</zip>
        <telephone>+98 86 4622 1533</telephone>
        <email>rheum.nursing@gmail.com</email>
        <affiliation>Khomein University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ashraf Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qods Blvd.</address>
        <city>Khomein</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>38817-43364</zip>
        <telephone>+98 86 4622 1533</telephone>
        <email>najm54@yahoo.com</email>
        <affiliation>Khomain University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being at the age of over 18 years old
having 2nd and 3rd grade pressure ulcers
the same antibiotic use in all patients</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>any susceptibility to the use of herbs
certain vascular damage such as Burger disease
the presence of combined skin problems.
bone involvement
bone visibility
sepsis caused by wound infections
malignancy
connective tissue disease
Vasculitis
known case of immune system disorders
Corticosteroid use
chemotherapy
radiotherapy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention consists of placing a layer of herbal ointment consisting of honey, Plantago major L and Rosa damascene on the wound (bed sore) to the required amount (based on the size, amount and type of secretion of the wound), after washing and scrubbing (rinsing with 0.9% normal serum serum) Which was covered with a layer of sterilized gas. Wound dressing was carried out in both groups under equal conditions (number of dressing changes in 24 hours, duration and manner of washing). In this study, to prepare this ointment, 1.5 grams of the Plantago major L in 25 ml of water and 1 g of the Rosa damascene in 25 ml of water are brewed and mixed with 50 g of honey and For every dressing, was used. After preparing the ointment, pouring some ointment in a can for each patient and labeling the name of each patient on the can were done. Dressing was done by two trained observer (one man and one female) about the method of dressing the bed sore, one to three times a day (depending on the condition of the wound) until complete wound healing. Observers took an observation measure (PUSH: pressure ulcer score for healing) before the intervention and then every week at a specified hour to determine the instrument scores. The Braden tool was used to control the confounding factors such as patient mobility, sensory perception, skin moisture, degree of physical activity, and nutritional status of patients.</i_keyword>
      <i_keyword>Control group: The intervention involves placing a layer of Comfeel on the wound (bed sore) to the required amount (based on the size, amount and type of secretion of the wound), after washing and scrubbing (rinsing with 0.9% normal serum serum) Which was covered with a layer of sterilized gas. Wound dressing was carried out in both groups under equal conditions (number of dressing changes in 24 hours, duration and manner of washing). Dressing was done by two trained observer (one man and one female) about the method of dressing the bed sore, one to three times a day (depending on the condition of the wound) until complete wound healing. Observers took an observation measure (PUSH: pressure ulcer score for healing) before the intervention and then every week at a specified hour to determine the instrument scores. The Braden tool was used to control the confounding factors such as patient mobility, sensory perception, skin moisture, degree of physical activity, and nutritional status of patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound healing score according to the PUSH tool. Timepoint: Before and after 4 weeks of intervention. Method of measurement: PUSH tool.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Khomain University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-18</approval_date>
        <contact_name>Ethics Committee of  Khomain University of Medical Sciences</contact_name>
        <contact_address>Qods Blvd Khomein Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
